Cleared Traditional

K951060 - KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRN

K951060 is an FDA 510(k) clearance for KARL STORZ KOH NEEDLE HOLDERS, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K951060 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
14d
Days
Class 2
Risk

K951060 is an FDA 510(k) clearance for the KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE .... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 16, 1995 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K951060

510(k) Number K951060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1995
Decision Date March 16, 1995
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1070
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K951060.
KARL STORZ FIBER OPTIC LIGH CABLES
K950811 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K951173 · United States Surgical, A Division of Tyco Healthc · Mar 1995
CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE
K951082 · Stephen Chakoff, Inc. · Mar 1995
NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES
K951086 · American Hydro-Surgical Instruments, Inc. · Mar 1995
NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA
K946089 · American Hydro-Surgical Instruments, Inc. · Mar 1995
LAPAROSCOPE, HAND INSTRUMENTS
K950103 · Olympus America, Inc. · Mar 1995